Cleared Traditional

K993553 - GTI-FVIII INHIBITOR ASSAY
(FDA 510(k) Clearance)

K993553 · Genetic Testing Institute · Hematology

Feb 2000

Decision

104d

Days

Class 2

Risk

K993553 is an FDA 510(k) clearance for the GTI-FVIII INHIBITOR ASSAY, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Genetic Testing Institute (Brookfield, US). The FDA issued a Cleared decision on February 1, 2000, 104 days after receiving the submission on October 20, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number	K993553 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 1999
Decision Date	February 01, 2000
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF